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| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 06/05/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Product identification records for the alleged gore device were not provided.Therefore, a review of the manufacturing records could not be performed.It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." the gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
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Event Description
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It was reported to gore that the patient underwent laparoscopic ventral incisional hernia repair on (b)(6) 2014 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2020, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infected mesh, abscess, mesh removal, drainage, and pain and suffering.Additional event specific information was not provided.
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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: [ni] [not indicated] implant procedure: laparoscopic ventral incisional hernia repair with 34- cm x 24-cm gore ptfe dualmesh.Implant: gore ptfe dualmesh [ni/ni, 34- cm x 24-cm] implant date: (b)(6), 2014 (hospitalization unknown) ¿ (b)(6) 2014: (b)(6)clinic.(b)(6), md.Operative note.Preoperative indication: recurrent ventral incisional hernia.Preoperative diagnosis: recurrent ventral incisional hernia.Postoperative diagnosis: recurrent ventral incisional hernia.Preoperative procedure: laparoscopic ventral incisional hernia repair with mesh.Second assistant: (b)(6), rnfa.Anesthesia: general.Estimated blood loss: less than 30 ml.Other: preoperative antibiotics given intravenously.Indication for procedure: patient presented with a history of previous midline incision as well as previous ventral incisional hernia repair.She had developed a large ventral incisional hernia along her midline.Risks, benefits, and alternatives to laparoscopic repair with mesh were discussed with the patient in detail.She agreed with placed operation.Description of procedure: patient was brought to operating suite and placed in supine position under general anesthesia.Foley catheter was placed.She was prepped and draped in usual sterile fashion including a ioban steri-draped across her abdomen.Veress needle was used to insufflate the abdomen under the left costal margin.A 5-mm optiview trocar used to enter the abdominal cavity.Two additional 5-mm trocars were placed in the left lateral abdomen.Patient had adhesions of omentum and some small intestine to the midline.There were filmy adhesions, which were then taken down sharply with scissors.All adhesiolysed surfaces of the small intestine were inspected.There was no evidence of any injury to the intestine.We then inspected the hernia.It went down to the suprapubic position.The peritoneum over the bladder was incised so that we could identify the superior border of the bladder.This was swept down easily.This allowed us to identify cooper¿s ligaments bilaterally.Additionally, the peritoneum was inspected.There was no evidence of any recurrent endometriosis in the abdomen.At this point, spinal needles and intra-abdominal ruler were used to measure the extent of the defect, which was 24 cm vertically and 10 cm horizontally.The ruler was then removed.A 34-cm x 20-cm gore ptfe dualmesh was then fashioned with a 0 gore-tex suture on each side of the four sides.It was rolled and brought into the abdominal cavity through a 12-mm trocar, which was placed in the midline so it would later be covered by the mesh.The mesh was unrolled.An intra-abdominal grasper was then used to measure a 5-cm overlap in all directions from the fascial defect and sutures brought up through the anterior abdominal wall using a suture passer.The mesh covered the defect very nicely with good overlap.The mesh was then tacked to cooper¿s ligament bilaterally.It was then tacked circumferentially using spiral tacks.Care was taken not to placed any tacks below ileopubic tract to avoid cutaneous nerve entrapment.Additional transabdominal fixation sutures were then placed every 4 to 5 cm circumferentially around the mesh for transabdominal fixation.There was no evidence of any bleeding from tack or suture sites.The mesh covered the defect very nicely.All trocars were removed under direct visualization.No evidence of bleeding from trocar site.Sponge and needle counts were correct.Suture sites were infiltrated with a total of 20 ml of exparel long-acting liposomal bupivacaine, the skin closed with 4-0 monocryl suture and dermabond skin adhesive.The patient was awakened and taken to recovery room in stable condition.¿ ¿ product identification records for the alleged gore device were not provided.Explant procedure: removal mesh abdominal cavity.Revision scar torso.Explant date: (b)(6), 2020 (hospitalization unknown) ¿ (b)(6) 2020: [facility ni].(b)(6), md.Operative note.Preoperative diagnosis: infection mesh abdominal wall initial.Postoperative diagnosis: infection mesh abdominal wall initial.Panel 1: first assistant: (b)(6)., aprn, np-c, ms.Other assistant: (b)(6)., md.Panel 2: (b)(6), md ¿ primary.Anesthesia type: general.Full operative note details: patient presented with a history of prior abdominal ventral hernia repair with mesh in both 2010 as well as 2014.Between the 2 repairs she had a surgery with bowel resection.In the past several months she had developed some drainage from her midline wound.This was consistent with mesh infection.We discussed wound exploration, explantation of any of her prior mesh from 20/10, and possible removal of all of her mesh if infection tracked to the newer mesh from 2014.Description procedure: ¿patient brought to the operating suite in supine lesion [sic] under general anesthesia she was prepped and draped in usual sterile fashion.Her prior midline incision was opened sharply.She had a punctate 2x3 cm opening in the midportion of the wound with draining purulence.This was excised.Subcutaneous tissues open with electrocautery.This allowed us to identify prior prolene running stitches which seemed to be nidus for an abscess where the patient had drainage.All the identifiable prolene was removed.A small amount of prior prolene mesh was trimmed from the edges of her fascia.We could not identify any more polypropylene mesh.We did identify her laparoscopically placed ptfe mesh and the purulence did track down to this mesh as well.This was cultured.This mesh was then removed in its entirety.Care was taken to gently remove stitches and tacks from the abdominal wall as well as cooper¿s ligament.The entire mesh was removed.I had discussed her case with dr.(b)(6) prior to surgery.In the event that she had infection of both pieces of prior mesh we had counseled her that we would not attempt an abdominal wall reconstruction with mesh placement at this time to avoid any ongoing infection.The patient did have a rind of tissue over her intestines.There was no evidence of any connection to the intestines.This space was copiously irrigated.A 19 round drain was then placed in the retro muscular plane.The remaining fascia was closed with running looped pds suture.Subcutaneous tissues irrigated and a 15 french round drain placed in the subcutaneous space.Skin was closed with staples.Sterile dressing applied.Patient was awakened taken to recovery room in stable condition.¿ estimated blood loss: 50 ml.Implants: none.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information. it should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.Through gore's investigation and based on the available information there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® dualmesh® biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿¿ the instructions for use further warn: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.¿these may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.After multiple requests, specific lot number information was not provided for this device, but product type has been confirmed.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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